A Pilot Randomized Clinical Study Comparing Patient-Reported Outcomes and Complications for Mandibular Implant Overdentures Retained by Different Splinted Attachment Systems

NCT07373340 | Completed DMC

• 1 other identifier: M15011122
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory pilot randomized clinical study enrolled ten completely edentulous participants who experienced retention and stability problems with conventional mandibular complete dentures. Participants were randomly allocated to receive mandibular implant-supported overdentures retained by either a bar-locator attachment system (n = 5) or a bar-ball attachment system (n = 5). Denture satisfaction was assessed using the McGill Denture Satisfaction Questionnaire

Conditions

Edentulism

Keywords

implant; overdenture; bar

Outcome Measures

Primary Outcomes (2)

• patient-reported outcomes

  Patient satisfaction (primary outcome) between bar locator and bar ball using a McGill-based study at T0 and after 6 months of overdenture insertion

  Patient satisfaction (primary outcome) at T0 and after 6 months of overdenture insertion

• complications

  prosthetic complication between bar locator and bar ball

  prosthetic complication was evaluated From enrollment to the end of treatment at 3 years

Study Arms (2)

Group I (bar locator): Patients were given overdentures with bar locator attachments,

OTHER

Other: overdentures with bar locator attachments

Group2: Patients were given overdentures with bar ball attachments

OTHER

Other: overdentures with bar ball attachments

Interventions

overdentures with bar locator attachments OTHER

Patients were given overdentures with bar locator attachments

Group I (bar locator): Patients were given overdentures with bar locator attachments,

overdentures with bar ball attachments OTHER

Patients were given overdentures with bar ball attachments

Group2: Patients were given overdentures with bar ball attachments

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility criteria incomplete mandibular edentulism for at least one year, adequate bone volume in the interforaminal region to permit implant placement, a documented history of insufficient retention and/or stability with a conventional mandibular complete denture.

You may not qualify if:

• comprised uncontrolled systemic diseases, previous radiotherapy to the head and neck region, severe parafunctional habits, and any medical or local contraindications to implant surgery.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Heba Wageh

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

Denture, Overlay

Intervention Hierarchy (Ancestors)

Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 28, 2026
• Study Start: November 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

EG (1)